Status:
COMPLETED
Perfusion Enhancement With Respiratory Impedance in Stroke (PERI-Stroke)
Lead Sponsor:
University of Pennsylvania
Conditions:
Stroke
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a non-randomized phase 2 study designed to asses the mean flow velocity (MFV) and cerebral blood flow (CBF) response to non-invasive respiratory impedance.
Eligibility Criteria
Inclusion
- Age \> 18 years
- Ability and willingness to sign informed consent by patient or legally acceptable surrogate decision maker
- Acute ischemic stroke within 72 hours of study enrollment
- Imaging or examination confirming unilateral frontal lobe involvement in the stroke
Exclusion
- Hemorrhagic conversion of ischemic infarct
- History or presence of congestive heart failure, as defined by any of the following:
- Any preceding diagnosis of congestive heart failure as per patient report or medical record
- Report of moderate or severe systolic or diastolic dysfunction on prior
- Reduced ejection fraction, \<50%, on prior echocardiogram
- Jugular venous pulsations \>10 cm
- Pulmonary edema on chest radiography Of note, an echocardiogram is not required prior to study enrollment.
- History or presence of cardiomyopathy, as per medical record, patient report, or prior echocardiogram
- History or presence of pneumothorax or hemothorax
- History or presence of COPD
- History of current use of home oxygen
- Presence of pneumonia, as clinically determined by the primary medical team after admission chest radiography
- Age \< 18 years
- Skull defect that would interfere with CBF monitoring
- Pregnancy (urine or serum testing will required prior to enrollment of any pre-menopausal women)
- Structural brain lesion, including known primary tumor, metastatic tumor, or vascular malformation
- Prior neurosurgical procedure
- Any medical condition that the clinical investigator feels would pose a hazard to the subject if he/she participated in the study
Key Trial Info
Start Date :
September 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2017
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03476954
Start Date
September 1 2016
End Date
March 1 2017
Last Update
February 20 2024
Active Locations (1)
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1
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104